StrokeEarly Phase 1NCT04829071
Cognition and Motor Learning Post-stroke
A Early Phase 1 study testing Explicit motor learning and Implicit motor learning in people with Stroke and CVA (Cerebrovascular Accident), run by University of Southern California at 1 site in United States.
Trial summary
This project seeks to determine how post-stroke cognitive impairment moderates motor learning during walking in older adults with chronic stroke and identify brain structural markers that mediate this relationship. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Stroke, CVA (Cerebrovascular Accident)
- What is being tested?
- Explicit motor learning and Implicit motor learning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2023to 14 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral stroke
- Stroke occurred more than 6 months prior
- Paresis confined to one side
- Independently ambulatory (including the use of assistive devices)
- Able to walk for 5 minutes without stopping
- Answers no to all general health questions on the PAR-Q+
- Willingness to complete study procedures
Who cannot join
- Brainstem or cerebellar stroke
- Aphasia (expressive, receptive, or global)
- Any major musculoskeletal or non-stroke neurological condition that interferes with the assessment of sensorimotor or cognitive function
- Metal in the head (except in the mouth), implanted cranial or thoracic devices that violate MRI safety regulations
- Uncontrolled hypertension (>160/110mmHg)
- Concurrent physical therapy
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- Claustrophobia
- Significant cognitive deficit or dementia (<20 on MoCA)
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Center for Health Professions
Los Angeles, California, 90033
Kristan Leech, PT, DPT, PhD, 3124421583
About this study
Official title: Cognition as a Moderator of Motor Learning Post-stroke
This project seeks to determine how post-stroke cognitive impairment moderates motor learning during walking in older adults with chronic stroke and identify brain structural markers that mediate this relationship. The chosen experimental design integrates biomechanical analyses, neuropsychological assessments, and brain imaging techniques to determine the impact of post-stroke cognitive impairment severity on two forms of motor learning (explicit and implicit) and examine the role of the dorsolateral prefrontal cortex in the relationship between cognition and explicit motor learning. Ultimately, this work may lead to the development of a more comprehensive, effective treatment approach to improve walking dysfunction in older adults post-stroke.
- Conditions
- Stroke, CVA (Cerebrovascular Accident)
- Being tested
- Explicit motor learning, Implicit motor learning
- Keywords
- stroke, walking, rehabilitation, cognition
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Explicit motor learningBehavioural
Participants will be provided with visual feedback of their right and left step lengths on a screen in front of a treadmill.
Implicit motor learningBehavioural
Participants will walk on a treadmill that drives their right and left legs to move at two different speeds.
| Study group | Role | What they receive |
|---|---|---|
| Evaluating motor learning and brain structures post-stroke | Experimental | We will use a single arm design to determine the impact of post-stroke cognitive impairment on two forms of motor learning (implicit and explicit) and evaluate the structural integrity of relevant brain structures in 65 individuals post stroke Receives: Behavioral: Explicit motor learning; Behavioral: Implicit motor learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
step length asymmetry - change in performance
characterized as a comparison between the right and left step lengths; captured to quantify change in performance with biofeedback or split belt walking
Measured: Measured at three timepoints of interest within each testing session: baseline and at the beginning and end of the interventions; participants will complete 2 testing sessions over approximately 1 months
Secondary outcomes (1)
step length asymmetry - immediate retention
characterized as a comparison between the right and left step lengths; captured to quantify the retention of a newly learned walking pattern
Measured: Measured after motor learning in each testing session; participants will complete 2 testing sessions over approximately 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start16 Jan 2023
- Primary completion14 Aug 2026 (estimated)
- Study completion14 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristan Leech, University of Southern California
- Investigators
- Kristan Leech, PT, DPT, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829071
- Sponsor's protocol ID
- APP-21-00898
- Status last verified
- Oct 2025
- First submitted
- 30 Mar 2021
- Last updated
- 4 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified data from our research that underlie results in a publication will be made available on the Open Science Framework.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognition as a Moderator of Motor Learning Post-stroke
- ClinicalTrials.gov ID
- NCT04829071
- Acronym / sponsor ID
- APP-21-00898
- Conditions
- Stroke, CVA (Cerebrovascular Accident)
- Keywords
- stroke, walking, rehabilitation, cognition
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 14 Aug 2026 (estimated)
- Study completion
- 14 Dec 2026 (estimated)
- First posted
- 2 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project seeks to determine how post-stroke cognitive impairment moderates motor learning during walking in older adults with chronic stroke and identify brain structural markers that mediate this relationship. The chosen experimental design integrates biomechanical analyses, neuropsychological assessments, and brain imaging techniques to determine the impact of post-stroke cognitive impairment severity on two forms of motor learning (explicit and implicit) and examine the role of the dorsolateral prefrontal cortex in the relationship between cognition and explicit motor learning. Ultimately, this work may lead to the development of a more comprehensive, effective treatment approach to improve walking dysfunction in older adults post-stroke.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluating motor learning and brain structures post-stroke | Experimental | Behavioral: Explicit motor learning, Behavioral: Implicit motor learningWe will use a single arm design to determine the impact of post-stroke cognitive impairment on two forms of motor learning (implicit and explicit) and evaluate the structural integrity of relevant brain structures in 65 individuals post stroke |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Unilateral stroke
- Stroke occurred more than 6 months prior
- Paresis confined to one side
- Independently ambulatory (including the use of assistive devices)
- Able to walk for 5 minutes without stopping
Key exclusion criteria (9 listed)
- Brainstem or cerebellar stroke
- Aphasia (expressive, receptive, or global)
- Any major musculoskeletal or non-stroke neurological condition that interferes with the assessment of sensorimotor or cognitive function
- Metal in the head (except in the mouth), implanted cranial or thoracic devices that violate MRI safety regulations
- Uncontrolled hypertension (>160/110mmHg)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Explicit motor learningParticipants will be provided with visual feedback of their right and left step lengths on a screen in front of a treadmill. | Behavioural | Evaluating motor learning and brain structures post-stroke |
| Implicit motor learningParticipants will walk on a treadmill that drives their right and left legs to move at two different speeds. | Behavioural | Evaluating motor learning and brain structures post-stroke |
Primary outcome
step length asymmetry - change in performance
Time frame: Measured at three timepoints of interest within each testing session: baseline and at the beginning and end of the interventions; participants will complete 2 testing sessions over approximately 1 months
characterized as a comparison between the right and left step lengths; captured to quantify change in performance with biofeedback or split belt walking
1 secondary outcome
step length asymmetry - immediate retention
Time frame: Measured after motor learning in each testing session; participants will complete 2 testing sessions over approximately 1 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Individual participant dataSharing planned: Yes. All de-identified data from our research that underlie results in a publication will be made available on the Open Science Framework.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristan Leech, PT, DPT, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Explicit motor learning and Implicit motor learning in people with Stroke and CVA (Cerebrovascular Accident), run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristan Leech, PT, DPT, PhD ((323) 442-1583, kleech@pt.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
step length asymmetry - change in performance (time frame: Measured at three timepoints of interest within each testing session: baseline and at the beginning and end of the interventions; participants will complete 2 testing sessions over approximately 1 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.